Sep 27, 2018 in Healthcare

The Need of the Informed Consent for the Use of Human Cells

Introduction

It is not a secret that there has been an increased interest in the legal issues concerning the need of the informed consent for the use of human cells in medicine. In fact, it reached the status of an extensive issue within the realm of healthcare administration due to the need for conducting endless medical studies that aim at identifying the sources of different diseases and may be useful in finding medicines from cancer. Apart from the fact that the informed consent is always used in medical settings, it is worth mentioning that its legal side requires special attention due to the laws that were enacted in order to provide the patients with the right to make their own decisions. Thus, this particular debate takes into account two sides of the matter and seems to be a two-edged sword: the need for the informed consents as well as the potential advantages of using human cells in any cases are open to question. The legal issue of the informed consent is paramount in therapeutic and non-therapeutic settings in clinical research as it is a powerful tool to avert misunderstandings between the doctor and their patient. Nowadays, the informed consent has reached the level of indispensability.

The Informed Consent as an Obligatory Option in Clinical Practice

Being the stakeholders in particular researches, people in therapeutic and non-therapeutic settings should be properly informed of doctors’ intentions to use their cells for the sake of science and make voluntary decisions concerning the matter. It is needed to administer the consent in a just and fair manner for a conscientious investigator. Lim (2014) defined consent as the “voluntary agreement to or acquiescence in what another person proposes or desires” (p. 3). It is now universally accepted that people can decide themselves. This has resulted in higher standards of practice during the informed consent taking process.

In fact, as the informed consent means patient-oriented approach to medical treatments and further researches, people in therapeutic and non-therapeutic settings should be aware of their rights to make decisions. This approach is also based on the idea that doctors are obliged to give patients their own right to choose the treatment options after providing them with all the necessary information. According to Lim (2014),

Informed consent is now a central part of medical ethics and medical law. There has been a change in the public’s expectations of their role in medical decision making. The paternalistic approach by doctors is no longer acceptable. Today the patient has the right to receive and the doctor the obligation to give sufficient and appropriate information so that the patient can make an informed decision to accept or refuse a treatment option. (p. 3)

The above-mentioned fragment also suggests that, nowadays, patients can make their own decisions concerning the use of their cells in further studies. Ghooi (2014) states that “The voluntary consent of a subject participating in research is fundamental to the principle of autonomy. It is important that this consent is free from coercion, intimidation, falsehood, and physical, psychological, or economic pressure” (p. 3).

Ethical Implications

The reasons why doctors are not allowed to use human cells without the informed consent are closely tied up with a variety of ethical issues. Due to certain ethical dilemmas, the considerable weight is attached to the importance of using the informed consent in medical practice. One of them is based on using human cells for the sake of science and experiments that aim at improving the state of health indices worldwide. Basically, the need in human cells is determined by the importance of researches that identify different medical problems and try to solve them. Nowadays, among the most widespread reasons of this, one may find the use of human cells with the purposes of new strategies for therapy. However, without the informed consent, these experiments take the shape of inadmissibility. A proper way of informing patients of the fact that their cells may be useful in further researches should consist of the patient’s voluntary agreement to become the part of scientific research. Moreover, the proper informed consent requires understanding of the subjects – it seems to be the main condition on which the informed consent is based. For instance, the current use of the human cells in medical practice is directed towards studying cancer and birth defects. In this context, the subject should be given all the information that can influence his/her decision. Furthermore, attention should be paid to the matter of donation where the use of the informed consent is crucial and widely spread in general. The doctors ought to inform the patients of the potential risks and their right to refuse. Withholding the information from the patients results in breaking the law and further prosecution.

Legal Issues Surrounding the Informed Consent

It is reasonable to consider the reasons for enacting the laws concerning the informed consent. The absence of the informed consent in the previous centuries led to different problems and had adverse effects on people’s right. Viewing the historical background of this particular problem leads to the assumptions that the notion of the informed consent should be treated seriously by the doctors in regard to their patients. The matter is that in the past centuries, doctors made detrimental mistakes directed towards the patients because the notion of the informed consent had not existed before. The doctors took human cells for their experiments and used them for the sake of medicine and their researches. It is important to put an emphasis on the fact that treatment without the informed consent seemed to cause psychological breakdowns of the patients and their families. Although such demeanours cannot be justified, they led to the rise of prominence of the informed consent that took into account patients’ rights to make decisions concerning the use of their cells.

In the context of historical background, there were numerous cases that exerted tremendous impact on the medical law and destabilised it. The need for the informed consent for the use of human cells can be seen in the following cases and examples of violating human rights. Lim (2014) testifies that the changing trend of the informed consent has been shaped by public outrage that resulted from research atrocities as well as decisions made by courts of law. By the research atrocities, the author means neglecting basic human rights to live. Accordingly, there is a need to consider these particular research atrocities that influenced the revolution of the informed consent. Not being mentioned in the Hippocratic traditions, the notion of the informed consent was mainly elaborated due to the abandonment of human rights by doctors. Firstly, it is essential to put an emphasis on the events that took place during the Second World War. Among the researchers that made experiments on people for the sake of finding solution to medical problems, one can find Nazi doctors that experimented on prisoners, the U.S. racial discrimination of patients, etc. It is clear from the above information that researchers violated human rights to live.

Schloendorff and HeLa Cases

In the articles written by Lim (2014), one may find the first landmark court cases regarding patients’ dissatisfaction with treatment and the use of cells. The need for the informed consent for the use of human cells augmented due to the Schloendorff Case that occurred in 1914 when a doctor removed a fibroid from a patient without her consent. However, bearing in mind the previous points, one should take into account that the concept of informed consent originates from the Berlin Code enacted in 1900. The influence of the unsuccessful cases in medicine led to the implementation of the informed consent in practice. Quite an important issue concerning the informed consent regards the enactment of the Nuremberg Code as a result of experiments held on humans after the Second World War. That is to say, the Nuremberg Code established the main principles of unethical behaviour towards people, thus separating human beings from animals. Shuster (1998) dwells upon the importance of Nuremberg code in regard to the informed consent:

The primary reason for merging Hippocratic ethics and human rights into a single code was to resist the temptation of subordinating the human subject rights to the will of the researcher, while retaining the beneficent view of Hippocratic physician-researchers of the welfare of their subjects. Subordinating the rights of research subjects to the researcher's will is a major temptation when research is perceived as extremely important, and the anticipated results could substantially improve the care of future patients. (p. 978)

In fact, neglecting the need for informed consent has disastrous consequences. Bearing in mind the previous points, it is of great importance to mention the case concerning the use of human cells without a patient’s informed consent. Such case is represented in The Immortal Life of Henrietta Lacks, a thought-provoking book written by Rebecca Skloot (2011). However, the author calls the reader’s attention to the most detrimental one that is the need for informed consent for the use of human cells in different medical experiments that have been made on people for the sake of science. In this case, one has to deal with the notion of “benevolent deception” that was peculiar to the doctors that treated Mrs. Lacks. It lies in the assumption that doctors “withheld even the most fundamental information from their patients, sometimes not giving them any diagnosis at all” (Skloot, 2011, p. 85). Therefore, it is true that the doctors did not stick to the informed consent for using human cells in their research. It resulted in negative attitudes to the matter.

The Impact of the Informed Consent on Healthcare Administration and Management

The notion of the informed consent is particularly relevant in healthcare administration. A skilled and qualified healthcare administrator should be aware of the problems that may occur because of neglecting the need of the informed consent. The administrators at hospitals ought to keep order concerning this issue. Interestingly, the need for the informed consent for the use of human cells is marked with violation even nowadays. As a result, the new way to ensure the informed consent was elaborated by lawmakers. It consists in videotaping the process of the consent and is considered to avert negative consequences. In general, videotaping ensures the proper way of using the informed consent from the perspective of the research stakeholders. However, there are conflicting views concerning videography. It is worth noting that patients usually oppose to such an attempt because of the fear that it may outrage confidentiality. Nevertheless, the ways to protect confidential information exist. According to Ghooi (2014), the most effective method lies in controlling access to the records. Another conflicting view regards the aspect of expenses and increased costs. However, one cannot take it seriously due to the fact that the cost of cameras has significantly come down. Additionally, there are different ways and methods to make records of the consent process. Therefore, one should admit that the use of videography may become a good tool in improving the quality of the informed consent. It possesses a number of advantages, thus protecting subjects and investigators.

Financial Growth

Not surprisingly, the notion of the informed consent exerts an impact on the financial management of the organisation. It is due to the fact that the proper use of the informed consent can affect the outcomes of the organisation. In this context, it is important to shed light on the benefits of the use of human cells in clinical research by means of proper consent taking. Thus, taking the stance of medical progress and presenting an alternative viewpoint, one may see that with the help of human cells, scientists made great contributions to medicine. Henrietta Lacks’ (HeLa) immortal cells were mainly applied in finding a way out to treat polio. They were helpful in freezing tissues and cloning cells. Moreover, HeLa cells were used in order to reverse the damage of massive doses of radiation. They were applied by cosmetic and pharmaceutical companies in order to study triggers for cellular damage of skin. The new findings always influence the organisation’s outcome and change the financial aspect. Although videotaping of the informed consent is considered to be expensive, there are numerous advantages to using human cells with the expectations that nobody will suffer because of the doctor’s actions. According to Korobkin (2007), “Scientific progress depends not only on the skills of scientists and the availability of funding, but also on the ability of researcher to procure large quantities of human tissues” (p. 609).

Community Participation in Health Research

Nowadays, the informed consent for the use of human cells is considered to be the centre of contemplating ethical issues. The case with Nuremberg doctors should never be repeated and it is good will of every doctor to ensure that his or her patient’s decision-making process is taken into account in therapeutic settings. As there are many cases when the use of human cells is needed in the therapeutic environment, the role of the informed consent is sometimes vital to the lives of patients. The informed consent mainly aims at ensuring the autonomy and importance of a person’s choice. Thus, a researcher should bear in mind that their attitude to the subjects is of great significance. The notion of the informed consent should not be neglected or abandoned.

However, there are circumstances, in which doctors do not make the right decisions and do not use the informed consent as the basis for their future research. Usually, researchers procure a patient’s tissues and he or she is later not aware of such things as the case of Henrietta Lacks shows. Hyun (2008) is concerned about the suggestion that researchers can be unfair towards patients and their families. Therefore, today’s medicine can be marked with the need for the informed consent to stave off the danger of making experiments on people without paying attentions to their decisions. It is essential to provide people in therapeutic and nontherapeutic settings with the proper information concerning the study where their cells are involved.

The issue of the informed consent is crucial regarding the patient’s community. The matter is that the patients are in charge of their own bodies and it is up to them to decide whether doctors can use their cells or tissues with the purpose of conducting researches. Apparently, the enactment of the law concerning the informed consent established the rules of the proper information that should be given to the patient so that he/she could make a right decision. Thus, doctors cannot impose their views that somehow influence the decision-making process. Not surprisingly, the issue of the informed consent ensures patient’s participation in medical research. According to Wah (2014), “the research findings are applicable to the participants and community” (p. 23).

Conclusion

In conclusion, the paper deals with a controversial issue concerning the need for the informed consent in the use of human cells. It thoroughly studies the matter from the ethical, legal and medical perspective. This particular issue has a clear-cut reflection in healthcare administration and affects the organisations. The use of the informed consent is paramount due to the fact that it takes into consideration the patient’s interests and rights to make decisions concerning the use of their bodies in clinical researches. In fact, the informed consent influences the welfare of the patients taking into account their interests. Thus, the informed consent is indispensable and its role in healthcare takes primary position when it comes to clinical research that is based on the use of human cells.

References

  1. Ghooi, R. (2014). Ensuring that informed consent is really an informed consent: Role of videography. Perspectives in Clinical Research, 5(1), 3-5.
  2. Hyun, I. (2008). Stem cells from skin cells: The ethical questions. Hastings Center Report, 38(1), 20-22.
  3. Korobkin, R. (2007). Autonomy and informed consent in nontherapeutic biomedical research. UCLA Law Review, 54(605), 606-630.
  4. Lim, V. (2014). Changing trends in informed consent. IeJSME, 8(1), 3-7.
  5. Wah, M. J. (2014). Conducting research that is both ethical and responsive to the health needs of a developing country. IeJSME, 8(1), 19-23.
  6. Shuster, E. (1998). The Nuremberg code: Hippocratic ethics and human rights. The Lancet, 351(9107), 974-977.
  7. Skloot, R. (2011). The immortal life of Henrietta Lacks. New York, NY: Broadway Paperbacks.

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